The Case for Post-Experiment Consent

by Mohini Banerjee research assistant, The Hastings Center
April 29, 2014

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The issue of the ethics of delayed informed consent is discussed here.

Note that in some cases where delayed consent has been tried, it has not been viewed unfavorably by the patients who took part.

In a recent Friday Feedback, we took a look at a recent cardiology study called HEAT-PPCI that included a protocol that requested permission from patients after they were treated in the experiment. The discussion ranged widely for those who felt strongly in favor and against. Here, Mohini Banerjee, a research assistant at the Hastings Center in Garrison, N.Y., expands the issue and argues the ethical grounds for informed consent after the fact. Banerjee's research interests include ethics in research and legal regulation of science and technology. She graduated Phi Beta Kappa from Smith College with a B.A. in philosophy and logic.

In a clinical trial, obtaining patient permission after the fact may not be ideal, but that does not mean it is wrong. While many see informed consent as the bedrock of ethical medicine, it may manifest itself differently in context.

For example, a minimal risk intervention comparing the effectiveness of two standard and oft-used treatments, such as the HEAT-PPCI study conducted in Liverpool, England, is a case of delayed consent done well. What passed multiple U.K. oversight groups would not be legally permissible in the U.S.

However, instead of an outcry against patient rights, American healthcare professionals and ethicists should consider how these circumstances fulfilled the ethical obligations of learning healthcare systems. The HEAT-PPCI study compared the reactions of bivalirudin and heparin in patients needing primary percutaneous coronary intervention. Heparin significantly reduced negative outcomes.

A potential ethical dilemma arose when patients were first randomized into their respective trial arms and were asked to participate in a clinical study only after the procedure was performed. This protocol departs from current U.S. Code of Federal Regulations, which requires explicit statements by the patient or a designated surrogate on voluntariness to participate, protection of patient rights and welfare, and that the research cannot practically be carried out without alteration.

These rules would certainly prohibit any U.S. institutional review board from approving the HEAT-PPCI study. In the U.S., informed consent is deemed inviolable because fear of abuse against patients still looms from the first three-quarters of the 20th century. Yet, it may be beneficial to our healthcare system to amend those rules and alter our public outlook in specific, controlled circumstances.

Some would argue that in light of circumstances such as those in the HEAT-PPCI study, research should not occur expressly because one could not achieve informed consent ahead of time. This point of view maintains patient autonomy above all while preventing research directly linked to better patient care and outcomes.

The HEAT-PPCI study occurred in a learning healthcare system as comparative effectiveness research, the best candidate for amending informed consent while protecting patients and improving the quality of healthcare. The Institute of Medicine describes a learning healthcare system that generates knowledge "so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement of care."

Learning healthcare systems, where research and medical practice are supplied in tandem, actively challenge the traditional division between these domains. These systems allow clinicians to evaluate medical interventions with an efficiency that is revolutionizing medicine. For instance, when lacking consensus in the field, discovering the better standard care procedure ultimately saves lives and lowers costs.

Contribute to the common purpose of improving the quality and value of clinical care and healthcare systems

In cases such as the HEAT-PPCI study, these obligations need to be balanced. How they are reconciled becomes a statement of the relative value in these different obligations. Under certain conditions, the benefits of a well-designed comparative effectiveness study in healthcare outweigh the premium on full informed consent. Indeed, asking for informed consent before a study is not the only avenue for respecting patient's rights.

In cases where comparative effectiveness research is most needed, who receives which comparable treatment is usually a physician's preference. Therefore, the act of randomizing to a particular arm of the clinical trial would not present any meaningful difference in care for the patient.

This has fueled an ongoing debate in medical ethics on the necessary elements of a consent procedure in studies that compare the effectiveness of two standard care treatments. Faden, Beauchamp, and Kass argue that "some randomized [comparative effectiveness research] may justifiably proceed with a streamlined consent process and others may not require patient consent at all." They continue to argue that many of the consent guidelines "overprotect" patients from research that does not threaten what is important to them.

Some objections to any use of delayed consent refer to an erosion of patient trust through an unnecessary obfuscation of medical practices. Yet, in cases where delayed consent has been tried, it has not been viewed unfavorably by the patients who took part.

For example, a study conducted in the ICU of a tertiary referral hospital in Australia tested research participants' opinions of delayed consent for the randomized controlled NICE- SUGAR trial. The study found that "delayed consent to participate in a clinical trial that includes critically ill patients is acceptable from the research participant's perspectives."

Further, the HEAT-PPCI study gained delayed consent from all but three participants, signaling that they did not object to their involvement. In this particular case, consent before the HEAT-PPCI study occurred would have been substandard, and thus to have "consented" patients beforehand would have been more disrespectful.

As patients were admitted, they were in a compromised, pained state and needed immediate care. To have asked for consent at that juncture would have delayed that care and surmounted to no more than a signature with little comprehension. If minimal risk is presented to the patients, which it was for substituting bivalirudin or heparin, then respecting patient' rights and dignity accompanies being able to understand what they are being asked.

Because the patients' care proceeded almost exactly as it would have with or without the study, the patients were not uniquely imposed with nonclinical risks or burdens, and were given the best quality medical care available to them. It was unknown before the study whether heparin or bivalirudin presented a better treatment, and therefore patients would have been treated with one through an arbitrary decision.

Some may question the validity of permission given after the fact, since they could not go back and undo their participation. However, this instance of delayed consent demonstrates that in these particular cases our model should not necessarily be of permission. Since the clinical setting would not require a patient's permission to be given a standard care treatment, focus should instead be on patient overall awareness.

Streamlined consent, even when it is delayed, preserves a patient's ability to truly grasp what physicians convey. Respecting patient voices will always be an integral part of medicine, but as research oversight grows, it also presents limits.

Easing informed consent in limited and protected circumstances brings us closer to a medical system that is safer and more sustainable for all. The U.S. can look to Australia and the U.K. as examples of the acceptability of delayed consent ultimately in the service of higher-quality healthcare.

Banerjee disclosed no relevant relationships with industry.

Reviewed by Zalman S. Agus, MD Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner

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